FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
50090-6560
11-digit product format
500906560
Labeler code
50090
Product ID
50090-6560_9e4a9dac-8e00-4b2d-b3a1-2c9826e32e66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA074880
Marketing category
ANDA
Marketing start
1997-09-17
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui630208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6560-0Albuterol Sulfate3 mL in 1 POUCHSOLUTION33
50090-6560-0Albuterol Sulfate25 in 1 CARTONSOLUTION253
50090-6560-1Albuterol Sulfate75 in 1 CARTONSOLUTION753
50090-6560-1Albuterol Sulfate3 mL in 1 POUCHSOLUTION33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6560-0ML - Milliliter50090-656092f92e8c-34ec-4fc0-9ed0-d66fe8473ea212023-09-05
50090-6560-1ML - Milliliter50090-6560f21a7011-d7af-40de-b122-7ca696d2ca0912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6560ALBUTEROL SULFATE SOLUTION [A-S MEDICATION SOLUTIONS]3Current NDC, 4 package rows20230725_8f52f15f-3fb7-4b00-a19f-8721c5ac55db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 0.83 MG/ML Inhalation SolutionSCD8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 0.083 % Inhalation SolutionSY8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY8f52f15f-3fb7-4b00-a19f-8721c5ac55db3
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY8f52f15f-3fb7-4b00-a19f-8721c5ac55db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6560-05009065600025 POUCH in 1 CARTON (50090-6560-0) / 3 mL in 1 POUCH25 pouch2023-07-17NoNoCurrent
50090-6560-15009065600175 POUCH in 1 CARTON (50090-6560-1) / 3 mL in 1 POUCH75 pouch2023-07-24NoNoCurrent